LIKMEZ (ATI-1501) for Metronidazole Oral Suspension 500mg/5mL re-launched and commercial sales ongoing
Five U.S. government proposals submitted, totalling up to US$125 million
HALIFAX, Nova Scotia, June 25, 2025 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the "Company" or "Appili"), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced its financial and operational results for the fiscal year ended March 31, 2025 ("FYE 2025"), and provided an update on fiscal 2026. All figures are stated in Canadian dollars unless otherwise stated.
"The recent commercial re-launch of LIKMEZ® (ATI-1501), following new patent coverage through to 2039, marked a major milestone for Appili and our partner, Saptalis Pharmaceuticals, LLC ("Saptalis"). Appili was founded to develop ATI-1501, and it's rewarding to see our lead development program in the market," said Don Cilla, Pharm.D., M.B.A., President and CEO of Appili Therapeutics.
"As we look to fiscal 2026, we remain focused on driving continued sales of LIKMEZ, advancing ATI-1701 funded activities, and finalizing development plans for ATI-1801. In addition, Appili has submitted five non-dilutive funding proposals to the U.S. government, totaling up to US$125 million."
LIKMEZ (ATI-1501), re-launched in the U.S.
In May 2025, the Company's manufacturing and commercialization partner, Saptalis Pharmaceuticals, LLC ("Saptalis") re-launched LIKMEZ® metronidazole oral suspension, (500 mg/5 mL) in the U.S. LIKMEZ is the first and only FDA-approved, ready-to-use liquid oral suspension of metronidazole, developed specifically for patients who have difficulty swallowing tablets or who are sensitive to taste.
Metronidazole is widely used as a frontline oral treatment with millions of prescriptions written in the U.S. every year. The current tablet form of metronidazole is the only other approved oral form on the U.S. market, but its bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing often presents treatment compliance challenges. LIKMEZ is designed to fill this significant gap in the treatment paradigm with a taste-masked metronidazole oral suspension.
ATI-1701, Biodefense Vaccine Candidate with Funding Awarded from the U.S. Air Force Academy
ATI-1701, Appili's live-attenuated vaccine candidate for the prevention of tularemia, continues to progress under a Cooperative Agreement with the U.S. Air Force Academy ("USAFA Cooperative Agreement"), with total program funding allotted of approximately US$11.6 million.
During FYE 2025, Appili presented positive findings at the Military Health System Research Symposium and IDWeek 2024 demonstrating that a single dose of ATI-1701 provided full protection against lethal tularemia one year after vaccination. These results, combined with research highlighting the elevated risk of tularemia outbreaks in conflict zones, underscore ATI-1701's potential as a critical tool in protecting military personnel and addressing global biodefense needs.
In May 2025, Appili Director of Non-Clinical Research, Dr. Carl Gelhaus, Ph.D., together with researchers from the USAFA, and other U.S. based researchers published the manuscript, "The Immune Response to Francisella tularensis". The review consolidates recent findings on the immune system response to F. tularensis infections and suggests various means by which infections can be controlled. By examining diverse F. tularensis strains and animal models, the authors outline promising pathways for effective tularemia vaccine development.
Appili successfully completed a knowledge and technology transfer for the ATI-1701 drug substance manufacturing process to its selected Phase 1 contract manufacturing organization. Engineering batches were successfully produced in 2024 to support future development activities.
There is currently no approved vaccine for the prevention of tularemia in the U.S., or other major global markets, strengthening ATI-1701's position as a potentially valuable vaccine urgently needed on the market. The Company continues to engage with U.S. government agencies and other stakeholders to explore non-dilutive funding opportunities for the program.
ATI-1801, our Licensed Topical Antiparasitic Product with positive Phase 3 study data.
ATI-1801 is a novel topical formulation of paromomycin (15% w/w) under advanced clinical development for the treatment of cutaneous leishmaniasis, a disfiguring infection of the skin that affects hundreds of thousands of people around the world annually.
In response to Appili's recent Type B meeting request, the U.S. Food and Drug Administration ("FDA") agreed with the Company's proposed strategy to establish a scientific bridge between previous clinical trial material and new drug product batches. The alignment with the FDA, allows completion and submission of an NDA much sooner than if additional clinical data were required.
Appili expects to pursue non-dilutive funding and partnership opportunities with NGOs and government agencies which share the Company's focus on tropical diseases to implement the agreed-upon strategy and complete remaining development work.
ATI-1801 has received an Orphan Drug Designation from the FDA for the treatment of certain forms of cutaneous leishmaniasis. The Company is actively evaluating the eligibility of ATI-1801 for a priority review voucher ("PRV") which, if confirmed, would make ATI-1801 the second potentially PRV eligible program at Appili, joining ATI-1701, subject to renewal of certain legislation in the United States.
Update on U.S. Federal Government Funding Proposals
During the past quarter, Appili submitted an additional funding proposal to the U.S. government, bringing the total number of proposals to five, representing a combined potential award value of up to US $125 million. If awarded, these funds would support the advanced development of critical infectious disease products aligned with public health and biodefense priorities.
"Having successfully raised US$34.9 million in prior government funds, Appili has built a strong track record in government contracting, and we are well-positioned to execute on innovative programs aligned with public health agencies," said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili. "Securing additional non-dilutive funding remains key to Appili's strategy, enabling us to advance high-priority infectious disease products while maximizing shareholder value"
Aditxt Arrangement and Loan Extensions
Subsequent to FYE 2025, on May 30, 2025, Appili delivered its formal termination notice to Aditxt under the arrangement agreement dated April 1, 2024 (as amended) between, inter alia, the Company and Aditxt (the "Arrangement Agreement"). Under the Arrangement Agreement, the Company is entitled to a termination fee (the "Termination Fee") in the amount of USD$1.25 million payable by Aditxt upon termination of the Arrangement Agreement in certain circumstances. This Termination Fee is to be reduced by certain amounts previously paid to the Company by Aditxt to extend the outside date under the Arrangement Agreement. As of the date hereof, the amount of US$1 million remains payable to Appili on account of the Termination Fee.
In connection with the termination of the Arrangement Agreement, Appili has secured 3-month extensions to the amounts due under each of (1) the amended and restated secured loan agreement with Long Zone Holdings Inc. (the "LZH Loan"), and (2) the unsecured promissory notes with Bloom Burton & Co. Inc. (the "Bloom Burton Loan"). Pursuant to the terms of such extensions, all amounts owing under the LZH Loan and the Bloom Burton Loan, together with all accrued and unpaid interest, will be due on August 31, 2025.
Annual Financial Results
The Company prepares its financial statements in accordance with IFRS as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook - Accounting.
The net loss and comprehensive loss of $2.6 million or $0.02 loss per share for FYE 2025, was $1.2 million lower than the net loss and comprehensive loss of $3.8 million or $0.03 loss per share during the year ended March 31, 2024. This relates mainly to a $4 million increase in government assistance, relating to the USAFA Cooperative Agreement, a $1.4 million increase in other income representing waiver fees from Aditxt, $0.2 million decrease in general and administrative expenses, and $0.2 million decrease in business development expense, offset by a $1.7 million increase in research and development expenses, $1.8 million increase in financing costs and $0.4 million increase in foreign exchange loss.
On March 31, 2025, the Company had cash of $1.2 million compared to $0.1 million on March 31, 2024. The Company has included a going concern note in its financial statements for the FYE 2025. In particular, the Company is dependent in large part on successfully raising additional financing through equity and/or non-dilutive funding. For further details, please refer to the Company's going concern note in the Company's management's discussion and analysis (the "MD&A") for the FYE 2025.
As of June 25, 2025, the Company had 121,266,120 issued and outstanding Common Shares, 10,910,281 stock options and 37,139,874 warrants outstanding.
This press release should be read in conjunction with the Company's audited annual consolidated financial statements for the FYE 2025, and the related MD&A, copies of which are available under the Company's profile on SEDAR+ at www.sedarplus.ca.
About Appili Therapeutics
Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili's goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial resistant infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.
Forward looking statements
This news release contains "forward-looking statements", including with respect to the potential for partnered projects to be developed, the potential that Appili will receive government awards and / or contracts related to its proposal submissions, further anticipated milestones and the timing thereof, the Company's development plans and timelines with respect to ATI-1501, ATI-1701 and ATI-1801, the timing of any milestone and/or royalty payments in respect of ATI-1501, and the Company's expectations with respect to its ability to operate as a going concern and satisfy its ongoing working capital requirements. Wherever possible, words such as "may," "would," "could," "should," "will," "anticipate," "believe," "plan," "expect," "intend," "estimate," "potential for" and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company's management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, (i) the risk that the Company may not secure any government funding in respect of any proposal submitted prior to the date hereof, (ii) the risk that the Company may not be able to collect the Termination Fee in full or at all, (iii) risks relating to the ability of the Company to repay the LZH Loan and the Bloom Burton Loan as and when they become due, and (iv) those risks listed in the annual information form of the Company dated June 25, 2025, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.
Media Contact:
Jenna McNeil, Communications Manager
Appili Therapeutics
E: JMcNeil@AppiliTherapeutics.com
Investor Relations Contact:
Don Cilla, President and CEO
Appili Therapeutics
E: Info@AppiliTherapeutics.com
